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临床试验/NCT00802906
NCT00802906已完成不适用

Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy

Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
BCVA in EDTRS values

研究概览

简要总结

The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.

详细描述

To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • History of macular or chorioretinal inflammation
  • Lens / corneal opacities

研究组 & 干预措施

1

Active Comparator

1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs

干预措施: subthreshold micropulselaser (Device)

1

Active Comparator

1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs

干预措施: bevacizumab (Drug)

2

Active Comparator

initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs

干预措施: subthreshold micropulselaser (Device)

结局指标

主要结局

BCVA in EDTRS values

时间窗: 24 months

次要结局

  • OCT, leakage in FA, defects in satic perimetry(24 months)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Koss

PI

Johann Wolfgang Goethe University Hospital

研究点 (1)

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